CLINICAL TRIAL

Increase morning bright light for Shift-Work Sleep Disorder

High Risk
Recruiting · < 18 · All Sexes · Pittsburgh, PA

This study is evaluating whether a new treatment may help reduce substance use in teenagers.

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About the trial for Shift-Work Sleep Disorder

Eligible Conditions
Delayed Sleep Phase Syndrome · Sleep Disorders, Circadian Rhythm

Treatment Groups

This trial involves 2 different treatments. Increase Morning Bright Light is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Monitor sleep, mood, and substance use
BEHAVIORAL
Sleep Scheduling
BEHAVIORAL
Increase morning bright light
OTHER
Decrease evening blue light
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Monitor sleep, mood, and substance use
BEHAVIORAL

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Physically and psychiatrically healthy
Provision of written informed consent and assent
Typically enrolled in a traditional high-school with synchronous learning (in-person or online synchronous learning, but not cyber- or home-schooling) [school closures during the COVID-19 pandemic are an exception to this]
Additional inclusion criterion for Experimental protocol: Meets operational definition of late sleep timing (>11:45PM habitual bedtime)
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Continuously up to every 6 months for up to 5 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Continuously up to every 6 months for up to 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Continuously up to every 6 months for up to 5 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Increase morning bright light will improve 7 primary outcomes and 2 secondary outcomes in patients with Shift-Work Sleep Disorder. Measurement will happen over the course of Baseline vs. 2 weeks.

Change from baseline in Circadian alignment at 2 weeks
BASELINE VS. 2 WEEKS
This is measured as the interval between dim light melatonin onset and midsleep.
BASELINE VS. 2 WEEKS
Change from baseline in Sleep timing at 2 weeks
BASELINE VS. 2 WEEKS
Assessed by 14-day wrist actrigraphy
BASELINE VS. 2 WEEKS
Change from baseline in neural correlates of reward anticipation at 2 weeks
BASELINE VS. 2 WEEKS
This outcome will be measured during the Money Incentive Delay Task, which is a computerized an fMRI behavioral task. It will be assessed by activation within the reward network, specifically, activation is defined as bold signals in regions of the reward network (particularly the ventral striatum) on reward anticipation trials versus no money trials.
BASELINE VS. 2 WEEKS
Change from baseline in neural correlates of impulse control at 2 weeks
BASELINE VS. 2 WEEKS
This outcome will be measured during the Stop Signal Task, which is a computerized an fMRI behavioral task. It will be assessed by activation within the Executive Control Network, specifically, activation is defined as bold signal in regions of the Executive Control Network (particularly the inferior frontal gyrus) on correct Stop trials versus correct Go trials.
BASELINE VS. 2 WEEKS
Change from baseline in behavioral reward motivation at 2 weeks
BASELINE VS. 2 WEEKS
Assessed by adjusted average pumps on Balloon Analogue Risk Task, a computerized measure of risk taking behavior in which participants are presented with a series of balloons and offered the chance to earn money by pumping each balloon up by clicking a button.
BASELINE VS. 2 WEEKS
Change from baseline in sleep duration at 2 weeks
BASELINE VS. 2 WEEKS
Assessed by 14-day wrist actigraphy
BASELINE VS. 2 WEEKS
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Who is running the study

Principal Investigator
B. H.
Prof. Brant Hasler, Associate Professor of Psychiatry, Psychology and Clinical and Translational Science
University of Pittsburgh

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes shift-work sleep disorder?

Data from a recent study suggest that a number of factors are involved in the development of Shift-work sleep disorder, and that environmental, genetic, familial and psychosocial factors all play a role in the development of this sleep disorder in shift-working women.

Anonymous Patient Answer

How many people get shift-work sleep disorder a year in the United States?

shift-work sleep disorder has a prevalence of 4% in a sample of U.S. nurses. This disorder may cause substantial harm to health and personal well-being. Recommendations regarding the need to control nesiritide exposure and sleep disturbance while working rotating shifts, especially during night shifts, should be investigated.

Anonymous Patient Answer

Is increase morning bright light safe for people?

Bright morning light might decrease wakefulness, especially during the first hour of work. Bright morning light was safe in our healthy group of normovigilant workers. Bright-light exposure during daylight saving time (between 20-22:00) should be a safe option to reduce sleepiness in the workplace.

Anonymous Patient Answer

What are the signs of shift-work sleep disorder?

SHFSD is frequently present in the general population and affects more males than females. The prevalence of insomnia, and insomnia symptoms, are also high among the population. Males are more more frequently reported to complain of SHFSD than females. Sleepiness is a frequent complaint. Shift-work sleep disorder is closely related to a variety of sleep, psychopathology and health-related disorders such as depression, anxiety and alcohol or benzodiazepine use (hypnotics). Therefore, SHFSD should be included in sleep screening procedures.

Anonymous Patient Answer

Can shift-work sleep disorder be cured?

In a recent study, findings does indicate that the present state of the science concerning shift-work sleep disorder has the potential to alter current knowledge about sleep and the functioning of circadian systems, which may affect future interventions.

Anonymous Patient Answer

What are common treatments for shift-work sleep disorder?

The most common treatment for NMS is behavioral intervention (CBT and motivational interventions in combination), often in combination with medications. NMS may be effectively treated in order to restore sleep efficiency and sleep quantity.

Anonymous Patient Answer

What is shift-work sleep disorder?

SHSWD is more prevalent in the working population than what is found in the general population. A history of shiftwork is associated with SHSWD, emphasizing the importance of sleep hygiene for the prevention of sleep disruption at night.

Anonymous Patient Answer

What is the latest research for shift-work sleep disorder?

The majority of studies have been published during or after 1997. Nevertheless, more than half of the literature reviewed dealt with the association between shift work and sleep problems. In spite of this, shift work sleep disorder remains a relatively unexplored topic.

Anonymous Patient Answer

What is the primary cause of shift-work sleep disorder?

Shifts are associated with an increased risk of shift-work sleep disorder. Shift workers may have worse sleep outcomes than day workers even if they meet all sleep and circadian requirements. The contribution of sleep fragmentation and circadian rhythm to shift-work sleep disorder warrants further research.

Anonymous Patient Answer

Who should consider clinical trials for shift-work sleep disorder?

The shift work disorder is common in young adults and has significant impact on quality of life, especially for women. Moreover, this study provides clues for the design of clinical trials on sleep disturbances associated with shift work disorder.

Anonymous Patient Answer

Have there been other clinical trials involving increase morning bright light?

As of February 2004, the number of clinical trials that investigated morning bright light for treatment of Shift-work sleep disorder is limited; however, a number of these tests demonstrate positive results involving this treatment. As clinical trials continue, it is hoped that additional evidence may lead to the recommendation of bright morning light therapy as a standard treatment.

Anonymous Patient Answer

Is increase morning bright light typically used in combination with any other treatments?

In addition to light exposure alone, morning bright light therapy is typically used in combination with another photic intervention. Further research is required to identify the optimal timing of morning bright light therapy.

Anonymous Patient Answer
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